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Acceptance Testing
New York and many other states require that new imaging equipment
be tested before first use on patients. This is also recommended
in the ACR Standard of Practice and in their Accreditation programs.
UMP has extensive experience providing acceptance testing for new
imaging equipment, including radiographic and fluoroscopic X-ray,
C-arms, CT units, Nuclear Medicine cameras, PET and PET/CT units,
MR units, mammography equipment, CR readers and PACS workstations.
Through our thorough testing and measurements, we have been able
to help clients verify that their equipment meets manufacturer specifications
and regulatory requirements, as well as identify any problem areas
that will need to be addressed to ensure that their substantial
investment in new equipment is maximized.
Most of our clients have felt that the cost of acceptance testing
by an independent, experienced physics group is extremely worthwhile
when compared with the overall cost of the new imaging equipment.
They are especially grateful on those occasions when we have discovered
significant problems that require correction before patient imaging
begins (and before full payment is made).
We believe acceptance testing by an independent physics group such
as ours is akin to having your car or house inspected by an independent
party prior to purchase. It’s a relatively small investment
for a fairly complex piece of imaging equipment. In past acceptance
testing for other clients, we have identified issues that had required
corrective action by the vendor. We have built excellent collaborative
relationships with local service engineers, because we work together
to ensure your imaging equipment works at its optimum performance.
Q&A
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Are there any requirements for acceptance testing?
Some states, like New York, require acceptance testing of all medical
diagnostic equipment before first use on patients. “Diagnostic
equipment,” includes Nuclear Imaging Systems (SPECT and PET),
CR readers and plates, and PACS workstation displays. This clarifies
the common misconception that acceptance testing is only required
for x-ray producing equipment.
Click
Here for the link to the NYS regulation
for Acceptance Testing.
Can acceptance testing be done by the manufacturer?
In New York State, the Medical Physics Licensure Law (Article 166
of the Education Law) specifies that acceptance testing is one of
the practices that may only be performed by a licensed medical physicist.
In section 8702, under the “definition of the practice of
medical physics” that “Acceptance testing” is
listed within the scope of practice.
Note that the education law is not typically enforced by NYSDOH
inspectors. The Medical Physics licensure law does not restrict
unlicensed persons from acquiring data, but rather requires oversight
from a licensed medical physicist.
The bottom line is that, in New York State, Part 16 (Health Law)
says that all diagnostic imaging equipment
must be acceptance tested, and Article 166
(Education Law) specifies that acceptance
testing must be performed by a licensed
medical physicist.
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Shielding Design
Protection of employees, patients, and the general public from primary,
scattered, and leakage radiation is the primary goal of shielding
design. UMP has provided shielding recommendations for hundreds
of diagnostic installations, including radiographic, fluoroscopic,
CT, nuclear medicine, PET, and PET-CT imaging equipment. We use
the latest methodologies described in NCRP 147, to provide you with
accurate, concise reports. We also have substantial experience with
providing the paperwork required for Certificate of Need (CON) projects.
We strive to balance our main objectives of safety and regulatory
compliance with cost and prudent design on every job. UMP can work
directly with the architectural or construction firm, as needed
and can provide expert advice on layout and other design features.
We also offer quick turn around times for rush projects (3-day is
available for single room projects).
Shielding design has really changed in the past 30 years. It has
always been prudent to perform a shielding design for a new or renovated
facility. With the latest changes in CT technology, we find that
most existing CT scanner rooms need additional shielding to safely
accommodate the new multi-detector CT scanners and their greatly
increased mAs workloads. Because many facilities cannot verify the
amount of existing lead in x-ray rooms, we are able to make an on-site
determination of the existing lead, helping to maintain safety and
minimize unnecessary expense.
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Consulting –
Regulatory, Quality Control, Technology
Medical imaging is becoming anything but simpler. Not
only is the technology becoming increasingly complex,
there are a multitude of regulatory requirements and
quality control tests that change continually. We pride
ourselves in providing prompt, professional advice on
regulatory, quality, and technology issues for all our
clients. Your answer is just a short phone call or email
away. When necessary, UMP consults with a network of
colleagues in the regulatory, manufacturing, and physics
communities.
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Procedures &
Manuals
Most regulators and accreditation organizations (such
as JCAHO) require imaging departments to have current
written procedures that document routine department
activities. Written procedures also help to ensure all
affected employees are aware of expected practices.
UMP has written concise, straight-forward procedures
and manuals for numerous clients, and can tailor documents
to fit most any format.
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Fetal Dose Estimates
When a pregnant patient is inadvertently exposed to
diagnostic medical radiation, it is important to know
the dose to the fetus. Based on imaging parameters provided
by the client, UMP can provide an estimate of the fetal
dose from diagnostic X-ray, CT, PET, or nuclear medicine
procedures, and compare the dose to acceptable guidelines.
Click
Here for an X-ray Fetal Dose Estimation
worksheet.
Click
Here for a CT Fetal Dose Estimation
worksheet.
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Radiation
Safety Training
Radiation safety training is integral for
technologists, physicians, nurses, and others
who may be exposed to radiation in the course
of their work. Most regulators require initial
radiation safety training for occupationally
exposed workers, and an annual or periodic
refresher.
UMP has provided hundreds of radiation
safety presentations to all levels of staff.
Our experienced instructors, who themselves
regularly attend professional meetings and
seminars, ensure that the most current information
is provided, and can tailor courses to fit
the needs of your facility. Contact us for
more information.
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Personnel
Dosimetry Analysis and ALARA Program
Whether film badges, TLD or OSL badges are
used, management of personal monitoring
systems and records are very important from
a safety, regulatory and legal standpoint.
UMP has helped clients with their dosimetry
program in several ways:
- Review of dosimetry reports and generation
of ALARA reports (Investigational Levels
I and II)
- Investigations of high doses with follow-up
regulatory support, if warranted
- Determination of which employees require
a dosimeter by reviewing past histories
and potential for exposures
- Reviewing the latest available client
records online via the vendors website
(e.g., Landauer, Global Dosimetry)
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Radiographic
and Fluoroscopic Equipment Evaluation
Periodic performance evaluations are performed to insure the equipment
is performing to manufacturer’s specifications essential for
optimal image quality results. The performance tests, set by regulatory
agencies, include: collimation, kVp accuracy, radiographic timer,
mR/mAs linearity, tomography, fluoroscopic image quality, AEC performance,
exposure switch, interlocks, half value layer, fluoroscopic timer,
fluoroscopic exposure rates, and SID indicator accuracy.
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Magnetic
Resonance (MR)
UMP has been performing MR Medical Physics
Surveys for about 10 years when we purchased
our first ACR MR Accreditation Program (MRAP)
phantom. Though not required by NYSDOH (since
no ionizing radiation is used), our clients
have asked us to perform this service in
increasing numbers over the past few years.
In 2005, the ACR MRAP has required that copies of the annual medical
physics survey be submitted with accreditation materials for each
scanner. Until 2005, the ACR would accept MRAP applications without
this documentation, but no longer according to Theresa Branham,
MRAP Manager at ACR.
The ACR MRAP Site Instructions recommend that facilities utilize
their medical physicist to assist with the phantom imaging (acquisition
and quantitative analysis) before these images are submitted to
ACR. We have performed this service for many clients over the years,
and have assisted with accreditation of more than a dozen MR scanners
in 2007.
Since the ACR issued their newest White Paper on MR Safety in June
2007, UMP has provided many facilities (and their architects and
planners) with guidance in design of new MR scanning suites and
recommendations for safety improvement for existing suites. UMP
is ready to help you to assure image quality, safety and assist
with MR Accreditation.
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Entrance Skin Exposure Analysis/Entrance
Skin Exposure Rates
ESE is the measurement of radiation output at the point
of skin entry for common X-ray examinations. Based on
our measured data and clinical techniques, we periodically
report ESE and ESER, comparing the results with regulatory
or advisory standards. Most importantly, we advise our
clients about whether or not any changes should be made
to provide optimized imaging at ALARA dose levels. With
CR and DR imaging, this has become even more critical,
since images obtained with too little or too much radiation
do not appear light or dark.
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